Catalog Number

020-032027

Brand Name

Bracepaste Band and Build LC

Version/Model Number

020-032027

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K896249

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

2da4eb6e-0806-43d8-bd8b-2ab1c0aaa8a1

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-